Adoption Blueprint

Historically how TIES and
TCRN was brought up at institutions. Our
hope is these documents will provide you with some insight and perhaps a
starting point for your project.

Overview

There are several phases to getting TIES up, running, and used at your institution:

  1. Installation
  2. Quality assurance
  3. Determine IRB requirements
  4. Determine policies for approval and account creation
  5. User training and engagement

In addition to these phases, to implement TIES, you may need details about other aspects, such as how TIES security works. These blueprints are intended to provide all of the information an institution might need to have a functioning TIES node.

Background Information

Included here is some general information about TIES that can be used to help different institutional stakeholders understand what TIES is and what the system uses.

Overview of TCRN Using TIES System – document giving a basic overview of the TIES system

System Overview – a more technical overview of the TIES system, including the architecture and different components

Resource Requirements – an overview of the hardware, software and personnel effort requirements.

DeID Evaluation – publication about De-ID, the de-identification system used in TIES

Installation Documentation

TIES Node Installation Plan – contains historical instructions about how to install TIES. No longer in use.

Security Documentation

TIES Security Overview – explains how TIES data is stored and accessed securely

TCRN Security Workflow for Data Only – diagram of the workflow for TIES Cancer Research Network (TCRN) data only requests (no tissue), including what is done by each institution and where data resides

TCRN Security Workflow for Data and Tissue  – diagram of the workflow for TCRN data and tissue requests, including what is done by each institution and where data resides, with additional steps addressing the Materials Transfer Agreement and transfer of tissue

Quality Assurance

To ensure TIES has been set up and is coding documents correctly at your institution, a QA procedure has been developed.

TIES Quality Assurance Plan – suggested QA procedure for verifying that documents are being de-identified and coded correctly. This procedure MUST be followed in order to join TIES Cancer Research Network (TCRN) to ensure sufficient de-identification and coding accuracy of documents on the network.

IRB Information

In order to use TIES at your institution, a TIES deployment IRB protocol will be needed that will cover use of TIES at your institution. In addition, your institution needs to determine what types of TIES studies need their own IRB protocol. For instance, for local TIES users at University of Pittsburgh, an IRB protocol is only needed for studies that require tissue. However, for TIES Cancer Research Network (TCRN) studies, an IRB protocol is needed for any study that requires report-level data.

The materials provided below can be used as a model for your own institution and modified as needed. Included is the TIES deployment IRB protocol from the University of Pittsburgh, the IRB form used at Pitt for TCRN studies, and guidelines for how users should fill out their IRB protocols for studies using TCRN.

Sample TIES Deployment IRB Medical Records Exempt Form – IRB exempt form that is part of the TIES deployment IRB at University of Pittsburgh

TCRN form for no human subjects determination – the IRB form used at Pitt  for TCRN studies. This form could be used as a model for the information your IRB needs investigators to provide about studies that use TIES.

IRB Guidelines for TCRN Data Only Projects – guidelines for how users at Pitt should fill out IRB protocols needing TCRN data. These guidelines could be modified to reflect what is needed by the IRB at your institution.

IRB Guidelines for TCRN Data and Tissue Projects – guidelines for how users should fill out IRB protocols needing TCRN data and tissue. These guidelines could be modified to reflect what is needed by the IRB at your institution.

Data Security Assessment – guidelines for how users should fill out Data Security Assessment protocol needing TCRN data. These guidelines could be modified to reflect what is needed by the IRB at your institution.

Policies and Approvals

You will need policies in place for approving TIES account requests and creating accounts. The following materials are used at University of Pittsburgh and can be adapted for your institution.

TIES Policies – local policy manual for TIES at University of Pittsburgh

User Access Checklist Form – checklist for approving or denying account requests

Honest Broker Checklist Form – checklist for approving/denying honest broker account requests